Trial Outcomes & Findings for RAL-eve Study: Raltegravir Substitution Study (NCT NCT00523237)

Results Overview

evaluate the percent of patients with viral load of \<50 copies at week 24 of study after being switched from enfuvirtide to raltegravir

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

24 weeks

Results posted on

2011-11-02

Participant Flow

Fourteen patients, all men, were enrolled.

All screened patients were enrolled into the study

Participant milestones

Participant milestones
Measure	Raltegravir 400 mg twice daily
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RAL-eve Study: Raltegravir Substitution Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raltegravir n=14 Participants 400 mg twice daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	56 years STANDARD_DEVIATION 56 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: With expected man baseline residual viremia of 5 copies/ml and predicted standard deviation of 3 in change of residual viremia, our study was predicted to have 80% power to detect a difference of 2.5 copies/ml in residual viremia with =0.05.

evaluate the percent of patients with viral load of \<50 copies at week 24 of study after being switched from enfuvirtide to raltegravir

Outcome measures

Outcome measures
Measure	Enfuvirtide Switch to Raltegravir Arm n=14 Participants patients were switched from Enfuvirtide to Raltegravir
The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir	86 percentage

Adverse Events

Raltegravir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Philip Grant, MD

Stanford University

Phone: 650-723-2804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place